The Rest of the Story: Tobacco and Alcohol News Analysis and Commentary

Tuesday, March 03, 2015

A study published in journal Regulatory Toxicology and Pharmacology reports that the two brands of electronic cigarettes tested - Blu and Sky Cigs - contain levels of hazardous chemicals that are almost all indistinguishable from levels in ambient air. The few chemicals that were detected were present at levels between 50 and 900 times lower than that in cigarette smoke.

No significant contribution of tested HPHC classes was found for the e-cigarettes."

The authors conclude that: "The deliveries of HPHCs tested for these e-cigarette products were
similar to the study air blanks rather than to deliveries from
conventional cigarettes; no significant contribution of cigarette smoke
HPHCs from any of the compound classes tested was found for the
e-cigarettes. Thus, the results of this study support previous
researchers’ discussion of e-cigarette products’ potential for reduced
exposure compared to cigarette smoke."

The Rest of the Story

This study adds to the abundant and growing body of evidence that electronic cigarettes are orders of magnitude safer than tobacco cigarettes and suggests that brands of e-cigarettes that do not overheat the e-liquid may be associated with very minor absolute health risks.

This should put an end to the assertions of many e-cigarette opponents that electronic cigarettes are not any safer than tobacco cigarettes. It exposes those public statements as being lies.

This research also demonstrates how misguided the FDA is in its scientific judgment. Despite all of the evidence, with numerous studies demonstrating results similar to those above, with studies showing rapid clinical improvement in smokers who switch to e-cigarettes, and with studies showing that the acute cardiovascular and pulmonary effects of smoking due not occur with vaping, the FDA is not sure that smoking is not any more hazardous than vaping.

In the deeming regulation proposal, the FDA stated: "Many consumers believe that e-cigarettes are "safe"
tobacco products or are "safer" than cigarettes. FDA has not made such a
determination and conclusive research is not available."
Clearly, the FDA does not believe that there is sufficient evidence at
the present time to conclude that cigarette smoking is any more
hazardous than vaping.

Furthermore, one of the problems noted in the deeming regulations
was the fact that: "The vast majority of the respondents who were aware
of these products indicated that they believed e-cigarettes were less
harmful than traditional cigarettes...".
Once again, the FDA is stating that smoking may not be any more hazardous than vaping.

Combined with the existing body of scientific evidence, this study blows out of the water the argument of e-cigarette opponents that we have no idea how hazardous vaping is and that we can't be sure that vaping is significantly safer than smoking.

Nevertheless, I'm sure electronic cigarette opponents will continue to make these assertions because they are being primarily motivated by ideology and not by science.

Monday, March 02, 2015

In an article published in the Ft. Wayne (IN) Health Sentinel, the executive director of the Indiana Youth Institute was quoted as stating: "If you used the entire (e-liquid) canister at one time, it would be the same as smoking 1 1/2 packs of cigarettes at one time."

The Rest of the Story

While it may be true that vaping one full cartridge of e-liquid is approximately equivalent to smoking 1 1/2 packs of cigarettes in terms of nicotine intake, it is certainly not true that vaping one cartridge of e-liquid is the same as smoking 1 1/2 packs of cigarettes. While vaping one cartridge will expose you to nicotine, propylene glycol and/or glycerin, flavorings, and potentially to some by-products such as formaldehyde and acrolein, smoking 1 1/2 packs of cigarettes will expose you to more than 10,000 chemicals, including more than 60 known carcinogens, as well as to radioactivity. So the statement that vaping one cartridge is the same as smoking 1 1/2 packs of cigarettes is blatantly false.

Once again, The Rest of the Story has caught an e-cigarette opponent lying about the relative health risks of smoking and vaping. This lie is a particularly damaging one because it insinuates that smoking is no more hazardous than inhaling vapor from a device which contains no tobacco and involves no combustion. The statement seriously undermines the public's appreciation of the severe hazards of cigarette smoking.

Why is it that e-cigarette opponents are apparently forced to lie in order to support their opposition to these products? The answer, I think, is that the truth simply does not support their position. The truth - based on current scientific evidence - is that e-cigarettes are helping millions of smokers in the U.S. to either quit or significantly cut down on the amount they smoke. And they are doing this without undermining smoking cessation, without causing ex-smokers to return to smoking, and without serving as a gateway to youth smoking.

Therefore, in order to craft a tenable position against e-cigarettes, its opponents have no choice but to fabricate evidence, to mislead the public, and to lie in their public statements. Telling the truth just doesn't provide support for their position; thus, the need to distort the science and/or lie to the public.

Friday, February 27, 2015

One of the most dramatic effects that has been observed in a large proportion of e-cigarette users who are not successful in quitting completely is a substantial reduction in the amount of cigarettes that they smoke. In fact, studies have shown that a solid majority of e-cigarette users are successful either in quitting or in reducing their cigarette consumption substantially. By substantially, I mean reductions around the order of 75% to 90% or higher.

A key argument used by e-cigarette opponents to demonize these products is that these huge smoking reductions have no health benefits because unless you quit completely, you are not improving your health. The opponents have to make this argument because if it were true that these substantial reductions in smoking were improving the health of smokers, then the public health benefit of these products would be enormous.

E-cigarette opponents have therefore attacked the phenomenon of "dual use" of both cigarettes and e--cigarettes as being a bad thing that does nothing for health. This allows them to include as benefits of e-cigarettes only complete cessation.

For example, on his blog, Dr. Stan Glantz argued that reductions in cigarette consumption are not a "meaningful clinical outcome."

The truth about this question is vital, as it has implications for most of the millions of vapers in the country. If dual use has no benefits, then any vaper who is not able to quit completely might as well just return to cigarette smoking.

And, in fact, if smokers/vapers believe what researchers like Dr. Glantz are saying, they are likely to indeed return to cigarette smoking.

However, the claim that there are no health benefits of substantially reducing cigarette consumption is one of the greatest myths in the anti-smoking movement.

The Rest of the Story

First of all, even if there were no direct health benefits from substantially reducing one's cigarette consumption, it would still have health benefits. Research has demonstrated that reducing cigarette consumption enhances the likelihood of complete smoking cessation. In other words, it is a first step along a pathway to cessation. This approach works for a large percentage of smokers. In fact, a study published earlier this week showed that using varenicline for smoking reduction is an effective technique for getting smokers to quit completely. If this works for varenicline, then it would be expected to work for electronic cigarettes as well.

But it turns out that beyond the above health benefit of substantial smoking reduction, there is, in fact, a clinically meaningful direct and immediate benefit.

The dangerous myth that has been disseminated by electronic cigarette opponents is based on the observation that a number of studies have found that severe smoking reduction does not reduce the risk for heart disease and is associated with only small reductions in cancer risk.

But what these e-cigarette opponents are forgetting (or ignoring and suppressing) is that smoking does not only cause heart disease and cancer. It also causes lung disease, and there is no question that severe smoking reduction decreases the rate of progression of lung disease and produces a dramatic improvement in respiratory symptoms. Any smoker who has accomplished such a reduction can tell you this.

This fact is demonstrated by a study which reports that asthmatic smokers who switched partially to e-cigarettes, thus becoming dual users, experienced a significant improvement both in their respiratory symptoms and their lung function. Dual users also experienced a significant reduction in asthma exacerbations.

It makes sense that even severe reductions in cigarette consumption will not decrease heart disease risk because the adverse processes caused by smoking that lead to heart disease saturate at very low levels of exposure. However, the risk of cancer is generally linearly related to carcinogen dose (this has been established for lung cancer), so one would expect to see some cancer risk benefit. But the area where one would expect to see the greatest benefit is respiratory health. It is the ongoing insults due to smoking that lead to progression of chronic obstructive lung disease. Greatly reducing smoking will slow that progression. But most importantly, greatly reducing cigarette consumption will improve respiratory symptoms in smokers who are experiencing them.

In my own clinical experience, substantial
smoking reduction unequivocally was associated with significant health
benefits. These patients experienced a dramatic reduction in their respiratory
symptoms, often making a significant difference in their quality of life.

There is no reason for e-cigarette opponents to continue to lie to the public about what they say is a complete lack of health benefit from substantial reduction in cigarette consumption. This propaganda is undoubtedly causing public health harm by convincing many smokers who cannot quit completely that it is not even worth cutting down.

Thursday, February 26, 2015

For decades, public health organizations have attempted to educate the public about the severe hazards associated with cigarette smoking, with tremendous success. However, in the past year or two, many of these same organizations have succeeded in completely undermining the public's appreciation of how hazardous smoking is. They have accomplished this, albeit unintentionally, through a campaign of deception about the hazards of electronic cigarettes.

In their zeal to demonize e-cigarettes, they have not only resorted to misleading and even lying to the public, but have done substantial public health damage. This damage comes in two forms. First, they have succeeded in convincing many smokers not to attempt to quit smoking. Second, they have succeeded in convincing about 50% of the public that smoking is not as hazardous as they previously thought.

The Rest of the Story

Today, I reveal a shocking finding that was reported two days ago in the American Journal of Preventive Medicine: Of all adults who have heard of electronic cigarettes, a whopping 49% believe that smoking is no more hazardous than using e-cigarettes, which contain no tobacco, involve no combustion, and have been found to significantly improve respiratory health in smokers who switch to them, even partially.

This undermining of the public's appreciation of the hazards of smoking has already taken its toll: smokers are being convinced not to quit. Many of them actually believe the propaganda coming from anti-smoking groups and researchers, and these smokers have therefore decided they might as well continue smoking rather than switch to electronic cigarettes. After all, if e-cigarettes are just as harmful as tobacco cigarettes, then what's the point of quitting smoking by substituting e-cigarettes?

In addition, for the same reason, some ex-smokers who have quit using e-cigarettes are deciding they might as well return to cigarette smoking.

Ironically, the roles of Big Tobacco and the anti-smoking community have completely switched. For years, we in public health tried to convince the public of how harmful smoking is, and the tobacco companies tried to undermine that. Now, the tobacco companies are telling the public that smoking is far more harmful than vaping, and it is the anti-smoking groups which are trying to completely undermine that understanding. And these new data demonstrate that they are succeeding.

In the piece, I argue that many anti-smoking and health groups, including the CDC and the California Department of Public Health, have been waging a war against e-cigarettes, but that this war is based on a campaign of deception. These groups are misleading the public, and sometimes even lying about the relative health effects and effectiveness of electronic cigarettes.

Further, I argue that this campaign of deception is working. E-cigarette use is tailing off or even decreasing, and this is due to the misleading information which is scaring smokers into thinking that vaping is just as hazardous as smoking, thus removing any incentive to quit smoking using e-cigarettes. This, I argue, is doing profound harm to the public's health.

In the piece, I also share my initial impressions about e-cigarettes, to demonstrate that I understand why anti-smoking groups are reacting in the way they are. However, whereas I changed my mind when I saw the scientific evidence and actually took the time to talk to vapers, many of the anti-smoking groups are so blinded by ideology that they have come to a pre-determined conclusion and don't actually care about the scientific evidence. Or, they are displaying the confirmation bias, where they interpret the evidence to fit their pre-existing conclusions.

Here is a brief excerpt from the piece:

"When electronic cigarettes came to the U.S. about 2007, I was
skeptical. My assumption was they were a ploy by the tobacco industry to
hook more people into smoking under the guise of being a safer
product—the notorious low-tar cigarette scam all over again. But as I
talked to many e-cigarette users, known as “vapers,” conducted research (Journal
of Public Health Policy, 2011) and reviewed a growing body of
scientific evidence, I became convinced that e-cigarettes have dramatic
potential for reducing disease and death caused by smoking."

"Yet
many in the antismoking movement—in which I have been involved for
decades—are conducting a misleading campaign against these products. And
this campaign may be doing harm to public health."

"The most common claim about e-cigarettes is that they are a “gateway” to smoking. In September 2013
Thomas Frieden
,
director of the Centers for Disease Control and Prevention, said “many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes.” He added that electronic cigarettes are “condemning many kids to struggling with a lifelong addiction to nicotine.”"

"These statements had no basis in fact when he made them, and the evidence is that they are bogus. One recent study
in the American Journal of Preventive Medicine (January 2015) suggests
that e-cigarettes are not acting as a gateway to smoking among youth.
Another study in
the journal Drug and Alcohol Dependence (February 2015) suggests the
addictive potential of e-cigarettes is substantially lower than that of
tobacco cigarettes." ...

"Bloomberg Business reported last summer that e-cigarette sales began to slip in the U.S., and their use by smokers may even be declining in the U.K. The
percentage of the public that believes smoking is more hazardous than
electronic cigarettes has fallen to 65% in 2013 from 85% in 2010,
according to a 2014 study in the American Journal of Preventive Medicine."

"This
is a tremendous lost opportunity. Vaping technology—or something like
it that may be developed—has the potential to be one of the greatest
antismoking breakthroughs. I would hate to see its promise wasted
because of misinformation by the very public-health authorities who
should be in the vanguard of reducing the harm from cigarettes."

Tuesday, February 24, 2015

Tomorrow marks the start of the annual meeting of the Society for Research on Nicotine and Tobacco (SRNT) in Philadelphia.

According to the 2015 meeting program, a major purpose of the conference is: "Through scientific exchange, integrate current research with implications for clinical practice." Specifically, a major focus of the conference is discussing recommendations for the treatment of smoking addiction, including the use of drugs such as Chantix and newer alternatives such as electronic cigarettes.

In fact, there will be at least 12 presentations on the use of Chantix for smoking cessation. In addition, there will be one talk on the potential suicide risk that has been observed in post-marketing studies of Chantix users. However, that talk is based on a published paper which concludes that "there is consistent evidence that varenicline
either does not cause increased suicide outcomes, or if it does, the
effect
is very small." That paper makes recommendations for the labeling of the drug.

In addition, there will be nearly 20 presentations on electronic cigarettes.

The Rest of the Story

This would be an awesome conference if it represented an objective, unbiased, and non-conflicted view of the scientific evidence regarding the benefits and risks of Chantix as well as the evidence regarding the relative safety and effectiveness of its chief competitor: electronic cigarettes.

So there's just one problem:

The conference is sponsored by ...

... you guessed it

Pfizer - the manufacturer of Chantix, the very drug whose clinical use will be discussed at the conference.

While there is nothing wrong with conducting clinical trials or other research studies funded by pharmaceutical companies, there is something wrong with having such companies sponsor scientific meetings at which clinical recommendations for the use of their very drugs are going to be discussed in what is supposed to be an objective manner.

By accepting the Pfizer sponsorship, SRNT is sacrificing the scientific
integrity of the conference.

There is no way that the conference can
objectively consider the role of Chantix (or electronic cigarettes, a Chantix competitor) as part of a broad, national strategy for smoking cessation
when the conference is being funded by the very manufacturer of one of these products.

Can you imagine if this conference were being sponsored by independent (not related to Big Tobacco) electronic cigarette companies? There would be an outrage in the anti-smoking community. People would immediately question the objectivity of the conference, especially as it pertains to the discussion of the role of e-cigarettes in national smoking cessation strategy and in clinical recommendations.

In fact, I would agree that if the conference were sponsored by electronic cigarette companies, that would preclude the possibility of truly objective consideration of the appropriate role of electronic cigarettes in a national smoking cessation strategy as well as an objective consideration of clinical recommendations for the use of electronic cigarettes.

The bias introduced by the Big Pharma sponsorship
of the conference is readily apparent. While there are multiple talks
about the role of Chantix in smoking cessation, noticeably absent from the conference
program are the following talks:

Suicidal ideation and completed suicide as adverse side effects of Chantix: should varenicline be taken off the market or its warning label be strengthened?;

Case reports of varenicline-related deaths among patients with no prior history of depression;

Population-based data show that smoking cessation drugs are not effective;

Population-based data show that cold turkey quitting remains the most effective strategy;

Problems of blinding in clinical trials of smoking cessation drugs; and

Weaknesses
of the transtheoretical model in explaining the process of smoking
cessation: the need for anti-smoking media campaigns rather than smoking
cessation drugs as the mainstay for a national smoking cessation
strategy.

In fact, the one talk that addresses the suicide risk associated with Chantix (and concludes that there may not be any risk) is being presented by a researcher who has received research funding and consulting fees from Pfizer!

Specifically, Dr. John Hughes - who will apparently tell the audience that there is no major suicide risk associated with Chantix - has conflicts of interest by virtue of his having consultancies, honoraria, and research grants/contracts with many pharmaceutical companies, including Pfizer.

It is completely inappropriate to have this conflicted scientist be the one to opine on the potentially fatal observed side effects of Chantix.

In a 2008 article published in the journal Drug and Alcohol Dependence (Volume 98, Issue 3, 1 December 2008,
Pages 169-178), Dr. Hughes disclosed that: "In the last 3 years he
has received research grants from the National Institute on Health and Pfizer Pharmaceuticals and Sanofi-Synthelabo Pharmaceuticals both of whom are developing smoking cessation treatments.
In the last three years, he has accepted honoraria or consulting fees
from the following profit or non-profit institutions regarding nicotine
or other drug abuse topics: Academy for Educational Development, Acrux
DDS; American College of Chest Physicians, Adelphi Consulting, Aradigm;
Atrium, Baltimore Research, Campus Consulting, Cambridge Press, Cline,
Davis and Mann; Concepts in HealthCare, Constella Group; Consultants in
Behavior Change; Cowen Inc, Cygnus, Edelman, Fagerstrom Consulting; Free
and Clear; Healthwise, Health Learning Systems, International Marketing
Systems, Insyght; Johns Hopkins University; Maine Medical Center, McNeil, Medicus, Nabi, National Institutes on Health; NCI Consulting, Pfizer Pharmaceuticals;
Pinney Associates; Research Triangle Institute, Shire Health London;
Temple University of Health Sciences; University of Arkansas, University
of Auckland; University of Cantabria; University of Greifswald;
University of Kentucky, University of Memphis, Warner Pharmaceuticals, Wolters Press, Xenova, and ZS Associates."

Thus, Dr. Hughes is essentially a walking conflict of interest with Big Pharma.

The rest of the story is that although its
main purpose is presumably to foster objective scientific consideration
of the issues regarding nicotine and tobacco control, SRNT is
apparently heavily funded by the pharmaceutical industry. This funding,
in my view, creates a substantial conflict of interest that precludes
the objective consideration of many important scientific issues; in
particular, the role of smoking cessation drugs as part of national or
international tobacco control strategies.

This is in no way to
fault the individual scientists who will present on these issues at the
conference. Nor is it to suggest that any wrongdoing is occurring. It
is merely to point out that the pharmaceutical sponsorship creates, by
its very existence, an unavoidable bias that precludes a truly
objective consideration of any scientific issue that may have
significant implications for the profitability of smoking cessation
drugs, and therefore, for their manufacturers who are conference
sponsors.

It is also important to point out that bias does not
necessarily have to be conscious. In fact, the most concerning bias is
that which could arise subconsciously by virtue of the sponsorship of
the conference by Big Pharma.

Monday, February 23, 2015

According to an article in the Gloucester (UK) Citizen, the health scare over electronic cigarettes has led many adoption agencies in the UK to prohibit anyone who uses e-cigarettes from adopting children. In fact, some districts preclude anyone who has used an e-cigarette in the past 12 months from adopting.

According to the article:

"A couple has been stopped from adopting a child after the would-be father was seen smoking an e-cigarette. The decision by social workers at Staffordshire County
Council came after the pair had passed a long series of tests to qualify
as parents. They were told they could not adopt if either of them had used an
e-cigarette in the past 12 months – despite experts saying that ‘vaping’
poses little or no threat to children in the home. The couple told The Mail on Sunday: “When there are so many
children desperate for a family and a stable home, to put up such
trivial barriers is ridiculous.” According to its investigation at least 13 councils in England ban e-cigarette users from fostering or adopting young children." ...

"Abigail’ and ‘Brian’, who do not want to give their real names,
approached the council in December 2013 after several failed IVF
attempts costing over £20,000. By
last September, having undergone medicals and interviews, and having
proved they were of sound character and financially capable of raising a
child, the pair thought they were on track to adopt. But when a social
worker saw Brian using an e-cigarette, everything changed. Brian, 45, said: ‘By then I’d stopped smoking completely
and hadn’t had a real cigarette in months. I was using e-cigarettes as a
cessation aid, to ease the nicotine cravings.’"

The Rest of the Story

This story really turns my stomach. Moreover, it is just heartbreaking. How misguided this policy is. How devastating the consequences. Due to the anti-smoking groups' dissemination of false and misleading information about the hypothetical consquences of vaping, actual harm is being done to many people.

This story reveals that not only is this harm being done to smokers who have decided to continue smoking rather than engage in a behavior that many health advocates say is as dangerous as smoking, but serious harm is also being done to smokers who have successfully quit using electronic cigarettes.

In other words, smokers who quit successfully using e-cigarettes are actually being punished for using e-cigarettes rather than an "FDA-approved" method.

The sad reality is that despite the most important ethical principle of medicine and public health being "to do no harm," the anti-smoking movement is doing tremendous harm, both to the public's health and to the lives of many ex-smokers.

That health is hardly the paramount value in tobacco control in 2015 is demonstrated by the fact that it's not the fact that you quit that is important, it's that you quit "the right way."

Thursday, February 19, 2015

According to a "fact sheet" on electronic cigarettes put out by the office of Washington governor Jay Inslee, cigarette smoking may be no more hazardous than using a product which merely heats nicotine and propylene glycol, contains no tobacco, and involves no combustion.

According to the policy brief:

"“Vaping” may not be safer than smoking traditional cigarettes."

What is the reasoning behind the governor's proclamation that smoking is no more hazardous than vaping?

"E-cigarettes emit more than water vapor."

The policy brief goes on to state that:

"Former smokers and new smokers may be attracted to e-cigarettes because of unproven claims that they are safer and more accepted than traditional cigarettes."

Governor Inslee concludes by calling for taxes on e-cigarettes and restriction of e-cigarette flavors.The Rest of the Story
I find it despicable that a state governor is publicly asserting that cigarette smoking may not be any more hazardous than vaping, given the abudant scientific evidence that electronic cigarettes are far less damaging to health than real ones.

The governor's action is undermining decades of public education about the severe hazards of smoking. Moreover, is essentially lying to the public, since it is widely accepted by reputable scientists that vaping is less hazardous than smoking.

The governor wants some of the tax revenue from the imposition of an e-cigarette tax to go to smoking prevention programs. But what's the point of having a smoking prevention program if, out of the other side of your mouth, you are telling the public that smoking is probably not very hazardous (since vaping is almost certainly not very hazardous)?

And why would you want to put a tax on e-cigarettes when such a tax will certainly result in more smokers sticking with their deadly smoking, rather than switching to e-cigarettes and potentially saving their lives?

The stated purpose of the e-cigarette tax is to prevent e-cigarette use. But preventing e-cigarette use - among adults - is tantamount to a campaign to encourage cigarette smoking because realistically, this is the alternative for most smokers who are considering using e-cigarettes. These folks are not deciding between NRT, Chantix, Zyban, electronic cigarettes, and smoking. They are almost by definition accepting the fact that they do not believe they can quit smoking using the traditional methods. So the choice is essentially electronic cigarettes or continued smoking. Why does the governor of Washington want smokers to choose continued smoking?

The governor's actions are essentially promoting cigarette use and protecting cigarette profits at the expense of the improvement of the public's health.

While one part of his proposed legislation - the restrictions on selling e-cigarettes to minors - makes sense, the other two major provisions - the e-cigarette tax and the limitation of flavors - would significantly harm the public's health by promoting cigarette smoking.

It is one thing for a state to do nothing about preventing smoking. That is completely unacceptable. But for a state to make public statements and push for legislation that would promote smoking is almost sickening to me. It really turns my stomach to think that this is what the anti-smoking movement has come to.

Wednesday, February 18, 2015

In 2015, even the cigarette companies readily acknowledge that cigarette smoking is much more hazardous than vaping, which involves no tobacco and no combustion.

Not so for the Utah Department of Health.

In a "fact" sheet, the Department asks the question "Are e-cigarettes worse or better than regular cigarettes?" and then answers it by stating:

"Since e-cigarettes are not yet regulated as tobacco products, there is
very little information about the ingredients of liquids or the
approximate exposure to harmful and potentially harmful constituents
when using e-cigarettes over the short-term or long-term. While several studies found lower levels of carcinogens in the
e-cigarette aerosol compared to smoke emitted by traditional cigarettes,
both the mainstream and the secondhand e-cigarette aerosol have been
found to contain chemicals known to cause cancer, birth defects or other
reproductive harm, including acetaldehyde, formaldehyde, lead and
nicotine. Nicotine is both a highly addictive drug and a neurotoxin that can
cause nausea, vomiting, sweating, and an increased heart rate. Even
though nicotine levels in e-cigarette refill solutions are often high
enough to be fatal to small children, the FDA does not regulate e-liquid
manufacturing. Recently, Salt Lake County Health Department partnered with the Center
for Human Toxicology at the University of Utah to measure the amount of
nicotine in 153 e-liquid samples the department obtained from retailers
around the county. In the study, 61% of the e-liquid samples differed
by at least 10% from the labeled nicotine content, with discrepancies
ranging from 88% less to 840% more than stated."

The Rest of the Story

It is quite clear that the Utah Department of Health is unwilling to acknowledge that e-cigarettes are safer than real cigarettes.

The Department provides a long-winded response to the simple question of whether e-cigarettes are safer than tobacco cigarettes, but none of the response actually answers the question directly. However, the response seems to imply that it is the Department's opinion that e-cigarettes are not safer than tobacco cigarettes, and I certainly believe that most readers will interpret the answer in that way.

Why is this public health department so afraid to acknowledge the truth: that e-cigarettes are much safer than tobacco cigarettes?

I don't believe it is because the health officials are inept scientists who cannot tell the difference between nicotine and tens of thousands of chemicals and nicotine plus a couple of chemicals. Instead, I believe it is because there is a firmly entrenched ideology that anything which looks like smoking is terrible and so cannot in any way be condoned.

This is reminiscent of other harm reduction debates, where opponents cannot bring themselves to supporting a much less hazardous alternative to drug use, despite the enormous public health benefits. Perhaps the best example are opponents to the use of methadone for heroin addicts. These opponents of methadone argue that addicts are still remaining addicted to an opiate, and all opiates are hazardous. That may be true, but the use of methadone instead of heroin has been documented to have enormous public health benefits. No needle use. No spreading of AIDS, hepatitis, and other infections. No risk of thrombophlebitis, abscesses, and endocarditis. No need to commit crimes to support the drug activity.

Sadly, opponents of e-cigarettes are relying on arguments that are nearly identical to those which were used by opponents of methadone. And in both cases, I believe that the arguments are largely driven by ideology, rather than science.

Tuesday, February 17, 2015

Today, I applaud Dr. John Wiesman - Secretary of the Department of Health for the state of Washington - for his immediate correction of his statement which I noted yesterday.

As I wrote yesterday, in a press release issued last week by Washington governor Jay Inslee, the state's
Secretary of Health (Dr. John Wiesman) was quoted as stating that active
smoking is no more hazardous than vaping.
The press release quoted Dr. Wiesman as follows: "This is an urgent health concern that must be immediately
addressed. Many kids believe e-cigarettes are safer, but scientific
evidence suggests they are not."

Apparently, immediately after becoming aware of my critique of this statement, Dr. Wiesman corrected it. The statement now reads: "This is an urgent health concern that must be immediately
addressed. Many kids believe e-cigarettes are safe, but scientific
evidence suggests they are not."

By changing "safer" to "safe," the statement has been corrected because it is indeed true that electronic cigarettes are not safe in an absolute sense.

The Rest of the Story

I applaud Dr. Wiesman for his immediate response and correction. This demonstrates tremendous scientific integrity, and I greatly respect him for that.

Anyone can make mistakes (I have made plenty), but a willingness to correct such mistakes is what is most important.

Now, I hope that the other anti-smoking and health groups which have made false or misleading statements about electronic cigarettes will correct those statements. Unfortunately, this is unlikely to occur, as while Dr. Wiesman merely made a mistake, the misleading statements by many other health groups are part of a deliberate campaign to demonize e-cigarettes.

Monday, February 16, 2015

In a press release issued last week by Washington governor Jay Inslee, the state's Secretary of Health (Dr. John Wiesman) is quoted as stating that active smoking is no more hazardous than vaping.

The press release quotes Dr. Wiesman as follows:"This is an urgent health concern that must be immediately
addressed. Many kids believe e-cigarettes are safer, but scientific
evidence suggests they are not."

The Rest of the Story

What exactly is the evidence suggesting that e-cigarettes are no safer than tobacco cigarettes?

It doesn't exist.

There is no such evidence, and even the tobacco companies do not claim that their cigarettes are just as safe as e-cigarettes. In fact, should such a company make such a claim, they would be immediately attacked by anti-smoking groups. But ironically, when a health official makes precisely the same claim, the major anti-smoking groups are silent.

Not only is this statement wrong, but it is damaging to the public's health. By convincing smokers that their smoking is no worse than vaping, it discourages many smokers from using e-cigarettes to quit smoking. It also leads ex-smokers who quit via e-cigarettes to revert back to smoking. After all, what's the point of remaining on e-cigarettes instead of real cigarettes if the e-cigarettes are just as hazardous?

For the life of me, I cannot remember a time when day after day, public health official after public health official lies to the public, undermines decades of education about the hazards of smoking, discourages smokers from quitting, and does profound public health damage. And all because of narrow adherence to an ill-advised but deeply entrenched ideology.

Thursday, February 12, 2015

In one of the most irresponsible and ill-advised recommendations I have heard from a physician in a few days, an Oregon physician has called for a complete ban on the sale of electronic cigarettes in Multnomah County.

The County Board is currently considering an ordinance that would ban the sale of electronic cigarettes to minors, but to this physician, that is not enough. He would like to see a ban on the sale of electronic cigarettes to anyone.

His reason:

"We are responsible citizens who want to see an addictive product with no
known benefits and a host of potentially dangerous hazards kept off the
market until we see proof that it won't hurt children."

The Rest of the Story

Curiously, nowhere in his commentary does this physician call for a similar ban on tobacco cigarettes, despite the fact that we have documentation of a host of dangerous hazards that smoking causes, including severe effects on children.

Why the special treatment for cigarettes, which kill hundreds of thousands of people each year in the U.S., over e-cigarettes, which so far have killed an estimated zero people in the U.S.?

The author suggests that the only purpose of e-cigarettes is to make money by generating new nicotine addicts and relieving withdrawal symptoms in existing addicts. But if that's the case, then why is he not calling for nicotine patches to be taken off the market, since their purpose is to make money for pharmaceutical companies by relieving withdrawal symptoms in existing addicts?

The author fails to realize, or to acknowledge, that electronic cigarettes have an amazing public health benefit: they help smokers quit. In addition, they help many smokers cut down on the amount they smoke and they reduce the level of addiction to smoking and nicotine.

Nor does the author provide any evidence that e-cigarettes create new nicotine addicts. There is currently no evidence that this is the case.

In a bizarre twist, the anti-smoking movement appears to be totally pre-occupied with demonizing electronic cigarettes and to have lost its focus on the actual product that is killing hundreds of thousands of Americans each year: the damn real ones.

Tuesday, February 10, 2015

In one of the most ironic twists in my 30-year career in tobacco control, the anti-smoking movement is doing more to harm the public's health than to protect it with respect to its position and actions on electronic cigarettes. What started as an exponentially increasing trend of dramatically rising quit attempts, successful quitting, and substantial cutting down due to e-cigarettes has now plateaued and may even be starting to decline, thanks to the inane actions of anti-smoking groups, which have successfully scared the public about e-cigarettes, so much so that they have convinced huge numbers of smokers that vaping is just as hazardous as smoking. The end result? A huge increase in the number of smokers compared to what we would have seen in the absence of the misleading and sometimes dishonest public health campaign against electronic cigarettes.

When electronic cigarettes first came onto the U.S market in about 2007, I, too, was skeptical. I assumed, incorrectly, that this was a new tobacco industry ploy to hook smokers, under the guise of being a safer product. I thought it was the low-tar scam all over again. However, I was willing to change my mind in response to scientific evidence, and as I learned more about the product, talked to many vapers, conducted initial research, and reviewed the burgeoning body of research on the topic, I came to realize that this was not a repeated of past tobacco industry ploys. In fact, until 2012, the tobacco industry had nothing to do with the promotion or sale of electronic cigarettes. Instead, these were bona fide products whose companies' value proposition was that they wanted to make combustible cigarettes obsolete. The entrance of Big Tobacco into the e-cigarette market has changed things, but not enough to challenge the basic ideas that electronic cigarettes are a threat to continued success of combustible tobacco products and that the greater shift in nicotine use from cigarettes to e-cigarettes, the greater the degree of improvement in the public's health.

Many anti-smoking advocates rightly pointed out that we must consider and weigh the costs and benefits of e-cigarettes. However, over the past three years, adequate research has been conducted to indicate that while the benefits of electronic cigarettes are immense, there are very few known costs. These products are not acting as a gateway to smoking among youth, they are not particularly addictive among youth, and they may even be serving as a deterrent to youth who might otherwise become addicted to cigarette smoking. Nor are these products enticing ex-smokers to return to nicotine use and then back to cigarette smoking. And finally, there is no evidence that e-cigarettes are hindering the quitting process for smokers who - if not for e-cigarettes - would have quit completely.

So we are left with a situation where the existing evidence all points in the direction that e-cigarettes are indeed a gateway. They are a one-way gateway away from combustible cigarettes and toward a much safer alternative product that is literally saving thousands of lives.

Are electronic cigarettes safe? Of course not. If they were absolutely safe, this wouldn't be a debate. By definition, harm reduction involves an alternative product that is much safer, but not safe in absolute terms. But e-cigarettes don't need to be absolutely safe. They need to be orders of magnitude safer than cigarettes, and it appears that they most likely are.

There are legitimate concerns about electronic cigarettes that need to be addressed. But none of the anti-smoking groups are actually working toward such ends. What is needed is simple: the FDA should set uniform safety standards for all e-cigarettes and vaping products. These standards should include things like leafproof containers, childproof packaging, no sale or marketing to minors, adequate warning labels and instructions to keep away from infants and children, battery safety, quality control standards for nicotine labeling and for production of e-liquids, modest regulation of flavorings (such as a ban on diacetyl), and regulation of the coil temperature to prevent overheating of the e-liquid.

Instead of working toward these much-needed regulations, which go far to allow the benefits of e-cigarettes to unfold while minimizing the risks, the anti-smoking movement has instead been demonizing these products, using a widespread campaign of cherry picking, misrepresenting scientific evidence, deception and sometimes outright lying. The campaign was worked. Huge numbers of smokers have been convinced (wrongly) that vaping is actually no safer than smoking. This has resulted in large numbers of smokers eschewing the opportunity to quit smoking using e-cigarettes and instead, remaining stuck on tobacco cigarettes.

It has been a tremendous lost opportunity for public health. I can only hope that the insanity ends soon, so that the promise of vaping technology - or something like it - will not be wasted. This has the potential to be one of the greatest anti-smoking developments in my lifetime. I hate to see it go down the tubes because of immovable ideology. And I especially hate to see it go down the tubes because anti-smoking groups are misleading and lying to the public.

Thursday, February 05, 2015

A study published yesterday in PLOS ONE reports that mouse respiratory epithelial cells exposed to e-cigarette vapor showed signs of oxidative stress and inflammation and that mice exposed to e-cigarette aerosol experienced impaired pulmonary bacterial clearance.

It didn't take long for the conclusion that e-cigarettes can cause pneumonia to be disseminated across the world. For example, a WKYC news article headline told readers: "Study Links E-Cigarettes to Increased Risk of Viral Infections."

In this article, one of the study authors was quoted as stating:

"We have provided strong evidence that the liquid used in
e-cigarettes, whether it contains nicotine or not, has negative effects
on the airways and on the lungs. The problem is,
these products aren't regulated and there are no standards to control
how much nicotine or other chemicals they contain. I think e-cigarettes
could prove dangerous, especially with long-term consumption."

The Rest of the Story

There's just one problem with the alarmist conclusion from the study and the alarmist headlines being spread by the media: they are inadequately supported by scientific evidence.

This study was conducted on mice, and we know that there are severe problems with extrapolating from findings in mice to clinically meaningful findings in humans.

All the study really demonstrated was something we already knew: that e-cigarette aerosol can cause respiratory irritation. We've known that for years. The question of whether that irritation could translate into clinically meaningful lung disease remains unanswered, and there certainly is no evidence at the current time to suggest that there are any clinically significant adverse lung effects, at least acutely.

In fact, the only existing clinical evidence is that switching from smoking to e-cigarettes can actually reverse one form of obstructive airways disease (i.e., asthma). That study concluded: " This small retrospective study indicates that regular use of e-cigs to
substitute smoking is associated with objective and subjective
improvements in asthma outcomes. Considering that e-cig use is
reportedly less harmful than conventional smoking and can lead to
reduced cigarette consumption with subsequent improvements in asthma
outcomes, this study shows that e-cigs can be a valid option for
asthmatic patients who cannot quit smoking by other methods."

The danger in extrapolating from this finding in mice to clinically meaningful effects in man is demonstrated by a nearly identical study which found that mice treated with aspirin exhibit impaired clearance of bacteria from their lungs. The study concluded: "When challenged with a sublethal inoculum [of aspirin], pretreated and immediately treated animals
demonstrated significant impairments in their ability to clear viable
pneumococci from the lungs; the inefficient pulmonary clearance was
associated with a marked attenuation in the ability of aspirin-treated mice to recruit granulocytes and macrophages into the bronchoalveolar spaces. Survival in mice administered aspirin
6 h after pneumococcal challenge was not adversely affected; however,
the pulmonary clearance and cellular response were significantly
impaired. We conclude that aspirin can disrupt host defense against pneumococci by blunting the normal pulmonary inflammatory reaction to organisms deposited into the lower respiratory tract."

Based on that study, would researchers conclude that aspirin causes pneumonia in humans? Should the author of that study have warned the public that based on his findings, aspirin could be dangerous? Should the media have disseminated to the public the widespread conclusion that "Study Links Aspirin to Increased Risk of Bacterial Infections?"

Clearly, such conclusions would have been premature (and, as it turns out, wrong). Thus, the dangers of extrapolating from mice to men.

Tuesday, February 03, 2015

A new study published this week in the journal Drug and Alcohol Dependence suggests that electronic cigarettes are far less addictive than tobacco cigarettes, and that their addiction potential is probably closer to that of nicotine gum.

The researchers surveyed: "(a) 766 daily users of nicotine-containing e-cigarettes with 30 daily
users of nicotine-free e-cigarettes; (b) 911 former smokers who used the
e-cigarette daily with 451 former smokers who used the nicotine gum
daily (but no e-cigarette); (c) 125 daily e-cigarette users who smoked
daily (dual users) with two samples of daily smokers who did not use
e-cigarettes."

The major findings were as follows: "Dependence ratings were slightly higher in users of nicotine-containing
e-cigarettes than in users of nicotine-free e-cigarettes. In former
smokers, long-term (>3 months) users of e-cigarettes were less
dependent on e-cigarettes than long-term users of the nicotine gum were
dependent on the gum. There were few differences in dependence ratings
between short-term (≤3 months) users of gums or e-cigarettes. Dependence
on e-cigarettes was generally lower in dual users than dependence on
tobacco cigarettes in the two other samples of daily smokers."

The authors concluded that: "Some e-cigarette users were dependent on nicotine-containing
e-cigarettes, but these products were less addictive than tobacco
cigarettes. E-cigarettes may be as or less addictive than nicotine gums,
which themselves are not very addictive."

The Rest of the Story

In contrast to the statements of many anti-smoking groups, which have been claiming that electronic cigarettes are as addictive as real cigarettes because they contain nicotine, the rest of the story is that electronic cigarettes do not appear to be anywhere close to cigarettes in terms of their addictive potential, and in fact, they are probably much closer to nicotine gums, which are not particularly addictive.

The primary reason for this is probably the inferior of delivery via electronic cigarettes compared to real cigarettes, a phenomenon that Dr. Eissenberg demonstrated in one of his previous studies.

While use of electronic cigarettes by youth remains an important concern, it does not appear that there is major potential for huge numbers of youth to become quickly addicted to these products, despite the fact that they contain nicotine. Even among formers smokers who "relapse" to nicotine use by using e-cigarettes, their level of dependence on electronic cigarettes appears to be less that the level of dependence that nicotine gum users display for the gum.

Interestingly, users of nicotine-containing e-cigarettes were only slightly more dependent than users of nicotine-free e-cigarettes, suggesting that the nicotine in e-cigarettes is not powerfully addictive as it is in cigarettes.

Let's face it. The cigarette companies have perfected the method to most efficiently and consistently deliver nicotine to the user in a way that maximizes addictive potential. The e-cigarette cannot come close. And it is not designed to come close. A huge part of the action of the e-cigarette is the simulation of smoking. The delivery of nicotine is only one component of the effectiveness of these products. In fact, in the clinical trial by Bullen et al., electronic cigarettes were not substantially different in their effectiveness whether they delivered nicotine or not.

This study should help allay the fears of electronic cigarette opponents who are claiming that huge populations of youth are going to quickly become addicted to nicotine via electronic cigarettes and then transition to active smoking. This does not appear to be the case, based either on conceptual grounds or actual observation.

Thursday, January 29, 2015

If I said the words "heavily biased report," "cherrypicks studies that agree with its position and ignores studies that don't," "uses studies in ways that the study authors say are inappropriate," most tobacco control advocates would assume I am talking about a historical Big Tobacco report. Little would they suspect that what I am actually referring to is a report by the California Department of Public Health.

Sadly, I am referring to precisely that. A newly-released report on electronic cigarettes from the California Department of Public Health purports to provide a scientific review of the topic. Today, I examine the information it presents about the efficacy of e-cigs for smoking cessation and the evidence upon which it bases its conclusion.

The report concludes that: "There is no scientific evidence that e-cigarettes help smokers successfully quit traditional cigarettes or that they reduce their consumption."

This conclusion is based on only one peer-reviewed, observational study, which "found that e-cigarette users are a third less likely to quit cigarettes, suggesting that e-cigarettes inhibit people from successfully kicking their nicotine addiction."

The Rest of the Story

The study upon which the report most heavily relies is the Vickerman study. This is the study which the report claims found that e-cigarette users are a third less likely to quit cigarettes. As I have explained
in detail elsewhere, the data from the Vickerman study cannot be used to
assess the effectiveness of e-cigarettes for smoking cessation. Instead of estimating
cessation rates among a cohort of smokers who made quit attempts using
these products, the study analyzed cessation rates of a large number of
smokers who had previously tried to quit using e-cigarettes but failed,
and then called a quitline because they had failed and wanted to try
again.
Then, they compared the quit rate among these smokers to that among
smokers without such a history of a failed quit attempt using electronic
cigarettes.

In other words, this study did not estimate quit rates among smokers
trying to quit using e-cigarettes. Instead, it estimated quit rates
among many smokers who were not using e-cigarettes in their quit attempt
at all!

The truth is that many of the electronic cigarette users in the study did not use electronic cigarettes in their quit attempts!
According to data provided in the paper, a full 28% of the sample of
electronic cigarettes did not use these products in their quit attempts.

It should be clear to readers that this study was poorly designed to
investigate the efficacy of electronic cigarettes.

Even the author of the study stated most clearly that it was not designed to examine the efficacy of e-cigarettes for smoking cessation, and that it could not and should not be used for that purpose: "The recently published article by Dr. Katrina Vickerman and colleagues has been misinterpreted by many who have written about it. It was never intended to assess the effectiveness of the e-cig as a mechanism to quit."

Moreover, Dr. Vickerman herself explained
that her results do not in any way indicate that electronic cigarettes
are less effective than NRT, stating: "It may be that callers who had
struggled to quit in the past were more
likely to try e-cigarettes as a new method to help them quit. These
callers may have had a more difficult time quitting, regardless
of their e-cigarette use."

While the California DPH report relies upon a survey, an unpublished presentation, and the Vickerman paper, none of which were designed to determine the efficacy of electronic cigarettes for smoking cessation, there have been three clinical trials which were designed specifically to answer this question. Two were conducted by Dr. Riccardo Polosa and colleagues in Italy. One was conducted by Dr. Bullen and colleagues in New Zealand. These three studies are the best and most rigorous scientific information we have on the efficacy of electronic cigarettes.

So here's a question:

In the California DPH's comprehensive report, how many of these 3 clinical trials did it consider in determining its conclusion regarding the effectiveness of electronic cigarettes for smoking cessation?

A. One
B. Two
C. Three

The answer is ....

....None of the above.

The report doesn't consider a single one of these clinical trials, none of which is cited in the report.

In conclusion, this report is severely biased. It draws conclusions about the efficacy of e-cigarettes from studies that were never designed to measure the efficacy of e-cigarettes. It cherrypicks the studies that support its pre-determined conclusion and excludes studies that don't support this conclusion. It doesn't cite a single one of the three clinical trials which provide the most rigorous evidence regarding the effectiveness of e-cigarettes for smoking cessation.

This is exactly the type of thing we used to see from the tobacco industry in the past. But the rest of the story is that a health agency is now using precisely the same shoddy science techniques. There is apparently so much hysterical zeal against electronic cigarettes that science has lost its rightful place in the tobacco control movement.

The CDHS report goes even further than most e-cigarette opponents by arguing that there isn't even any evidence that electronic cigarettes can help smokers reduce their consumption. But that is an outright lie. There is tremendous evidence that e-cigarettes help smokers reduce their consumption. In fact, even among smokers who had no interest in quitting, more than 50% were able to cut their consumption by at least one-half after trying e-cigarettes. Numerous other studies have documented the same phenomenon. Even the most vigorous e-cigarette opponents have acknowledged that e-cigarettes are often associated with a significant reduction in cigarette consumption.

I actually agree with many of the measures recommended by the CDPH report, such as requiring leakproof containers for e-liquids, requiring childproof packaging, and conducting public education campaigns to reveal the truth about these products (and especially, about the relative risks between smoking and vaping). However, I do not condone the use of shoddy science, reminiscent of the tobacco industry of old, in order to support the need for these actions. The truth is enough. And in public health, we should offer the public nothing but the truth.

Wednesday, January 28, 2015

Today brings evidence that not only is the misinformation coming from many electronic cigarette opponents unethical because it violates the public health principles of transparency and honesty, but the propaganda campaign is actually working.

In a Reutersarticle from Monday, state Senator Mark Leno is quoted as stating: "Whether you get people hooked on e-cigarettes or
regular cigarettes, it’s nicotine addiction and it kills. We're going to see hundreds of thousands of family members
and friends die from e-cigarette use just like we did from traditional
tobacco use."The Rest of the Story

There is absolutely no evidence to support the contention that e-cigarettes are going to kill hundreds of thousands of vapers. In fact, there is currently no evidence that e-cigarette use carries with it any mortality risk. Clearly, this policy maker is under the mistaken belief that e-cigarette use is as harmful as smoking.Where could he possibly have gotten that idea?Let's see .... could it be? ........SATAN?! (apologies to those who did not get the Church Chat reference)The answer appears to be much simpler. He most likely got this ridiculous idea from the propaganda campaign being waged by electronic cigarette opponents. Over the past few days and months, I have documented one story after another of major anti-smoking groups and agencies disseminating the false claim that vaping is no less hazardous than active smoking. This propaganda has come from reputable health agencies and groups, including the FDA, the American Lung Association, the American Thoracic Society, and the American Legacy Foundation, as well as from numerous physicians and public health practitioners. It should therefore come as no surprise that policy makers are picking up on this, believing it, and then relying on it to formulate e-cigarette policy.Making matters even worse, some of this misrepresentation and deception is occurring in the presence of severe financial conflict of interests which are being hidden from the media
and the public.

Where is the error in simply being honest and truthful to American consumers?

Tuesday, January 27, 2015

It appears that the FDA is following a pattern in seeking new directors and office heads. It is apparently looking to those who have financial conflicts of interest with Big Pharma. I have already discussed how Mitch Zeller - the head of the Center for Tobacco Products - came to FDA directly from a pharmaceutical consulting company. Yesterday, it was announced that the new head of the Office of Medical Products and Tobacco at FDA will be Dr. Robert Califf.

The press release describes Dr. Califf as follows:

"During his career, Dr. Califf has led many landmark clinical studies,
and is a nationally and internationally recognized expert in
cardiovascular medicine, health outcomes research, health care quality,
and clinical research. He is one of our nation’s leaders in the growing
field of translational research, which is key to ensuring that advances
in science translate into medical care. He was a member of the Institute
of Medicine (IOM) committees that recommended Medicare coverage of
clinical trials and the removal of ephedra from the market and of the
IOM’s Committee on Identifying and Preventing Medication Errors. In
addition, he served as a member of the FDA Cardiorenal Advisory Panel
and FDA Science Board’s Subcommittee on Science and Technology.
Currently, he is a member of the IOM Policy Committee and liaison to the
Forum in Drug Discovery, Development, and Translation."

The Rest of the Story

Despite the seemingly exhaustive review of Dr. Califf's many highly recognized roles, there is one small piece of information that was not provided.

It turns out that Dr. Califf has a strong conflict of interest by virtue of his long history of grant funding and consultancies for Big Pharma. These are precisely the companies he will now be regulating.

In a recent article published in the journal Metabolism, Dr. Califf is a co-author of a manuscript that reported the results of a clinical trial which tested the efficacy of two pharmaceutical agents in treating metabolic syndrome. The manuscript notes that: "The NAVIGATOR study was supported by Novartis, Inc., and was designed by
an academic executive committee in collaboration with the sponsor."

It does appear to me that there is a question about whether there might be a conflict of interest for a scientist with a substantial number of personal conflicts of interest with Big Pharma to be brought in to head a department which is involved directly in the regulation of those very pharmaceutical companies.

It may be that Dr. Califf has to recuse himself from varous decisions that directly affect these particular companies. However, the list of companies is so long that there may not be all that many drug reviews that do not pose a conflict of interest. Perhaps more concerning than this individual case is the pattern that seems to be emerging. Do we really want a rotating door between the FDA and the pharmaceutical industry and its consultants?

In what is becoming a daily occurrence, yet another public health practitioner has publicly claimed that smoking is no more hazardous than vaping.

In a letter to the editor published in the New York Times, Joshua Muscat - a professor of public health sciences at the Penn State College of Medicine - writes:

"The biggest concern about e-cigarettes is their potential to increase
nicotine addiction among young smokers, especially children, who would
not normally try tobacco. It is not likely that e-cigarettes are safer,
because their use may lead to increased and not decreased tobacco
smoking in young people."

The Rest of the Story
Whether e-cigarettes lead to smoking among young people or not is irrelevant to the issue of whether e-cigarette use is safer than smoking. Moreover, there is no evidence that e-cigarette use leads to increased smoking among young people. If anything, there is some evidence pointing in the other direction. But the main point is that it is simply not true that vaping is as hazardous as smoking.

By disseminating to the public the falsehood that vaping is just as harmful as smoking, medical and public health practitioners are actually discouraging many smokers from quitting. They may even be causing many ex-smokers, who quit using e-cigarettes, to return to active smoking. After all, if vaping is no safer than smoking, then what's the point of using e-cigarettes? You're better off smoking and getting the full enjoyment of the experience.

Michael Shaw notes the absurdity of the position of many public health practitioners in a column published at Health News Digest. He writes: "The FDA approved
products--patches, gums, and drugs--help "boost" that to about one in
ten, an abysmal "success" rate of 10 percent. Yet, the official line,
from the FDA and the CDC on down, is "stick with the FDA-approved
methods; don't even try anything else!"
Chief among that "anything else" are
e-cigarettes, loved by users--because they do help you quit--but almost
unanimously hated by officialdom. ... However, there are powerful forces against e-cigarettes, including the proverbial strange bedfellows. ... As to the strange bedfellows, e-cig
opponents include many public health departments, disease trade
associations, and a host of smoking cessation groups. Why on earth
should the American Lung Association be against e-cigs?"

That is a great question. Why are so many public health and anti-smoking groups against a product that is helping many smokers quit? But more importantly, why are so many public health and anti-smoking practitioners telling lies about the scientific evidence regarding the relative safety of vaping vs. smoking.
There is certainly room for a healthy debate about the appropriate role that e-cigarettes should play in public health promotion and the regulations that are necessary to maximize the potential benefits while minimizing the risks of these products. However, there is no room for lying to the public about the science.ADDENDUM: Dr. Gil Ross has an excellent column in the Daily Caller which highlights the misinformation being disseminated by the California Department of Health Services. Note particularly this important point: "the official line, from the FDA and the CDC on down, is “stick with the FDA-approved methods; don’t even try anything else!”
This amounts to advising desperate, addicted smokers to “quit, or die,” given the 90 percent failure rate of these products."

Monday, January 26, 2015

In statements that even the tobacco industry would not make, two physicians with the American Thoracic Society have publicly claimed that there is no evidence smoking is any more hazardous than the use of non-tobacco-containing, non-combusted e-cigarettes.

In a letter to the editor in the New York Times, Dr. Frank Leone - a pulmonologist who is chair of the American Thoracic Society's Tobacco Action Committee - claims that there is no evidence that e-cigarettes are safer than real cigarettes. In fact, he claims that it is too early to even suggest that e-cigarettes are likely to be much safer than smoking.

Dr. Leone writes: "There is not sufficient evidence to conclude that e-cigarettes are a safer alternative to regular cigarettes or that e-cigarettes actually help smokers quit. ... it is too early to suggest labeling saying 'it is likely that e-cigarettes are much safer than smoking.' That isn't reassurance; it's a marketing tactic."

Meanwhile, in an article in the Journal of the National Cancer Institute, Dr. Dona Upson - a member of the Tobacco Action Committee of the American Thoracic Society - also claims that there is no evidence vaping is any less hazardous than smoking.

These are shocking claims, given that e-cigarettes contain no tobacco and merely heat and aerosolize a solution of nicotine, propylene glycol, and glycerine, while cigarettes burn tobacco at very high temperatures, producing more than 10,000 chemicals which include more than 60 human carcinogens.

The statements are also shocking given the fact that a multitude of data now demonstrate that e-cigarettes are less toxic than tobacco cigarettes, including studies showing that asthmatic smokers who switch to e-cigarettes experience dramatic improvement in their symptoms, that the levels of virtually all carcinogens are much lower in e-cigarette aerosol than in tobacco smoke, and that unlike smoking, vaping does not cause endothelial dysfunction or decrements in spirometric pulmonary function tests.

And the statements are even more shocking given that the tobacco companies themselves have acknowledged that smoking is much more hazardous than vaping. Obviously, it would be quite advantageous for the tobacco companies to lie to the public and repeat the claim that these physicians are making. But the tobacco companies are not doing that. Ironically, they are the ones telling the truth about the relative hazards of smoking vs. vaping.

Adding to the shock, Dr. Leone states that there is not evidence to even suggest that e-cigarettes are likely to be less hazardous than smoking. In other words, he is claiming that it is not likely that smoking is any more hazardous than vaping. Based on the existing scientific evidence, I view that claim as being patently false.

It is not clear exactly what the American Thoracic Society's Tobacco Action Committee is smoking, but whatever it is, they are undermining years of public education about the severe hazards of smoking. They are also discouraging quit attempts by smokers and helping to protect the cigarette market, as the hysterical information they are disseminating may well scare some vapers into returning to smoking and may discourage smokers from quitting who might well have quit using e-cigarettes.

On the bright side, I at least applaud Dr. Leone for speaking out against hospital policies that refuse employment to e-cigarette users.

This story once again demonstrates how ideology, and not science, has taken over in the tobacco control movement.

Friday, January 23, 2015

Using information on type of atomizer studied in the recent New England Journal of Medicinearticle which claimed that vaping produces formaldehyde levels that pose a greater cancer risk than active smoking, Dr. Konstantinos Farsalinos has confirmed that the conditions used in the study (at the 5 volt level) were implausible.

The study reported finding high levels of formaldehyde in the aerosol of electronic
cigarettes, leading the authors to conclude that the cancer risk
associated with vaping is higher than that associated with smoking. The formaldehyde was not detected at the low voltage setting (3.3V), but was detected in large quantities at the high voltage setting (5.0V).

It turns out that the atomizer had a resistance of 2.1 ohms. At a voltage of 5 volts, the power delivered would be about 12 watts. This is clearly in the red zone, where the atomizer coil may be damaged or burned and the e-liquid would definitely be overheated. This would create an extremely unpleasant taste, and no vaper could tolerate more than one puff under these conditions (known as "dry puff" conditions).

The Rest of the Story

The implications of this story are that the conditions used in the high voltage setting in the study were implausible. Thus, the cancer risk estimation in the study is invalid, as is its conclusion that vaping poses a higher cancer risk than active smoking because of the high levels of formaldehyde.

To borrow an apt analogy from Dr. Farsalinos, it is like totally charring a piece of meat, detecting high levels of carcinogens, and then concluding that people who eat meat are at a very high risk of developing cancer. While it is absolutely accurate that there are high levels of carcinogens in charred meat, no one eats meat under such conditions, so the cancer risk estimation is completely invalid.

If you overheat an atomizer, it is going to result in aldehyde formation. This is because at very high temperatures, propylene glycol degrades (is oxidized) to form formaldehyde due to incomplete combustion. This process is enhanced with the presence of metals.

While the high voltage conditions were implausible, the low voltage conditions were not. Thus, the only valid conclusion from the study is that at low voltage conditions, the atomizer tested did not produce any detectable levels of formaldehyde.

Unfortunately, the alarmist (and incorrect) conclusions of this study have already been widely disseminated in the media. Even if the information is corrected, it appears that the damage is done.

I believe that the damage is substantial because many smokers will now become convinced that there is no advantage to switching from tobacco cigarettes to electronic cigarettes. This will discourage many smokers from quitting. It also may cause some vapers to return to cigarette smoking, since they may be convinced that smoking is no worse for their health.

It is difficult to imagine even the tobacco companies of old disseminating such a false conclusion about the relative "safety" of smoking. What the authors concluded is that smoking is safer than vaping, at least in terms of carcinogenic risk. While the tobacco companies undermined conclusions about the hazards of smoking, I don't recall them ever stating that smoking was as benign as a behavior for which no serious adverse effects had been observed. Regardless, my point is simply to emphasize the magnitude of the fallacious conclusion of this study and the damage that it has already done to the protection of the public's health.

Wednesday, January 21, 2015

A new study released today by the New England Journal of Medicine reports finding high levels of formaldehyde in the aerosol of electronic cigarettes, leading the authors to conclude that the cancer risk associated with vaping is higher than that associated with smoking.

The study examined the aerosol produced by a tank system electronic cigarette. The aerosol was collected and analyzed for formaldehyde. Two voltage settings were used: low (3.3V) and high (5.0V).

The main finding was that at low voltage, no formaldehyde was detected, but at high voltage, high levels of formaldehyde were detected. Using these levels, the authors extrapolate to derive an overall lifetime cancer risk from vaping, which they claim is higher than that from cigarette smoking.

The Rest of the Story

There's just one problem with the study, but this problem renders its conclusion invalid.

The conditions used to study the e-cigarette aerosol at the high voltage setting were unrealistic and under such conditions, a vaper would never be able to use the product. This is because the wattage being used was so high that the vaporizer was overheated (for a conventional e-cigarette it would likely damage or burn the coils), creating a horrible taste which a vaper could not tolerate. This is sometimes referred to as the "dry puff phenomenon."

Based on calculations by Dr. Konstantinos Farsalinos from data provided in the article, the resistance was no higher than 1.7 ohms. At a voltage of 5.0V, the wattage would be 14.7W. That is in the "red zone" where the vaporizer is being overheated and where, for a conventional e-cigarette, the coils would likely be damaged or burned.

Essentially, what this study demonstrates is that if you overheat a vaping system, it will produce high levels of formaldehyde. However, such conditions are not realistic, as they could not be tolerated by an actual vaper. Therefore, extrapolating from this study to a lifetime of vaping is meaningless.

On the other hand, the study does demonstrate a very important point. It is entirely feasible to produce an electronic cigarette or vaping system that does not deliver any measurable amount of formaldehyde. At the low voltage setting, no formaldehyde was detected. Rather than scaring people about the dangers of vaping and alarming them to the "fact" that vaping raises their cancer risk above that of smoking, we should instead be regulating the voltage and temperature conditions of electronic cigarettes so that the problem of formaldehyde contamination is completely avoided.

As I have argued before, instead of wasting its time and resources setting up a bureaucratic nightmare, where thousands of different products must submit pre-marketing applications, the FDA should simply promulgate basic safety standards. And one of those standards should set maximum voltage and temperature conditions for these products. That would minimize the health risks while maximizing the benefits.

ADDENDUM: Dr. Farsalinos has corrected me and pointed out that it is really the coil temperature, not the voltage, which needs to be controlled and regulated.

The California Department of Health Services (CDHS), under a grant funded by the Centers for Disease Control and Prevention (CDC), has produced a brochure entitled "Protect Your Family from E-Cigarettes: The Facts You Need to Know."

Here are some of the "facts" being disseminated by the CDHS:

1. "The aerosol is a mixture of chemicals and small particles that can hurt the lungs just like cigarette smoke."

2. "E-cigarettes are just as addictive as regular cigarettes."

3. "People can become addicted to nicotine from e-cigarettes and they may start using regular cigarettes."

4. "Studies show that e-cigarettes do not help people quit smoking cigarettes."

The Rest of the Story

The California Department of Health Services is lying to the public. Here is a brief analysis of each statement and an evaluation of its validity:

1. "The aerosol is a mixture of chemicals and small particles that can hurt the lungs just like cigarette smoke."

EVALUATION: Unsupported by scientific evidence

While it is true that there are a small number of chemicals in the aerosol of many electronic cigarette brands and there are certainly small particles, at present there is no evidence that these small particles can hurt the lungs just like cigarette smoke. In fact, there is strong evidence that electronic cigarette use does not produce the kinds of decrements in lung function observed with cigarette smoking.

2. "E-cigarettes are just as addictive as regular cigarettes."

EVALUATION: A lie

It has been quite convincingly shown that electronic cigarettes are not nearly as addictive as regular cigarettes. The nicotine delivery from e-cigarettes is quite poor and inconsistent in most brands. The delivery of nicotine from e-cigarettes is much lower than in regular cigarettes. Patterns of use of the product, especially among youth, demonstrate that the addictive power of e-cigarettes is much lower than that of tobacco cigarettes.

3. "People can become addicted to nicotine from e-cigarettes and they may start using regular cigarettes."

EVALUATION: Unsupported by scientific evidence

It has not yet been demonstrated that people can become addicted to nicotine from e-cigarettes. Certainly, people who are already addicted to nicotine from smoking may remain addicted to nicotine when they switch to electronic cigarettes. But there is as yet no evidence that nonsmokers who try e-cigarettes are at significant risk of becoming addicted to nicotine. More importantly, there is no evidence that people who start out with e-cigarettes are progressing to cigarette smoking. In fact, existing studies have failed to find more than a couple of youths who have started smoking after having been introduced to nicotine for the first time through e-cigarettes.

4. "Studies show that e-cigarettes do not help people quit smoking cigarettes."

EVALUATION: A lie

In fact, the opposite is true. Studies show that e-cigarettes do help people quit smoking. The existing studies suggest that e-cigarettes are about as effective as nicotine replacement therapy. It is possible that newer products are more effective for smoking cessation, but at very least, we can say that these products do help many people quit smoking.

While I commend the California Department of Health Services for putting out a pamphlet that warns parents that e-liquids are poisonous and urges them to keep these products away from young children, I condemn the Department for blatantly lying to the public. In their apparent zeal to demonize electronic cigarettes, the California Department of Health Services has crossed the line into unethical public health conduct, breaking one of the key principles: communicate honestly with the public.

That federal revenue is being used to support the dissemination of these lies makes this conduct even more egregious. I urge the CDC to cancel this contract with CDHS on the grounds that the Department is violating basic public health ethics by lying to the public.

Tuesday, January 20, 2015

In the most recent issue of the journal Alcoholism: Clinical and Experimental Research, a physician counsels all doctors to promote moderate alcohol use (one drink per day) among middle age, lifelong nondrinking patients. The author, Dr. Emanuel Rubin, is a pathologist at Thomas Jefferson University in Philadelphia.

(See: Rubin, E. (2014), To Drink or Not to Drink: That Is the Question.
Alcoholism: Clinical and Experimental Research, 38: 2889–2892.
doi: 10.1111/acer.12585.)

The major conclusion of the article is as follows: "The strongest evidence for a beneficial effect of moderate alcohol
intake is the documented reduction in all cause mortality and
cardiovascular disease. Indeed, the protection against coronary artery
disease is comparable to that produced by the administration of statins.
In this context, alcoholic beverages do not require a prescription, are
far cheaper, and are certainly more enjoyable. Although a physician's
advice to a patient should always be individualized, including a
consideration of a person's genetic background, the overwhelming
evidence suggests that physicians should counsel lifelong nondrinkers at
about 40 to 50 years of age to relax and take a drink a day, preferably
with dinner. The “black swan” predicts that the risk/benefit ratio is
highly favorable."

I don't know who the "black swan" is but he appears not to be a very good scientist. Calling "comparable" the scientific evidence linking statins to an improvement in heart disease risk with that linking moderate alcohol intake to lower cardiovascular disease mortality is scientifically unsound. The link between statin use and decreased cardiovascular disease is based on several double-blind, placebo-controlled, clinical trials, while the link between moderate alcohol intake and lower cardiovascular disease risk is based on observational studies that are plagued by the problems of selection bias and confounding.

People who do not drink at all are very different from those who drink moderately, and in ways that could influence heart disease risk. For example, there are often medical reasons why people don't drink alcohol. A number of medications recommend that alcohol not be used while on them. If these medical conditions and medications are associated with cardiovascular disease risk, which is highly plausible, then this would confound the relationship between observed heart disease risk and alcohol intake.

Moreover, even if it were true that a drink a day reduced heart disease risk, it does not necessarily follow that advising lifelong non-drinkers to start drinking would create net public health benefits. Since these are people who have not consumed alcohol for 20 to 30 years of adulthood (and perhaps not in childhood as well), it is quite possible that their ability to limit their alcohol intake once they start is not sufficient to keep them at only one drink per day. One of the reasons they are not drinkers may in fact be that they have a family history of alcoholism and are predisposed to alcoholism. A large increase in the number of drinking adults may well lead to an increase in youth alcohol use, since parental drinking is a known risk factor for underage drinking. Thus, for many reasons, Dr. Rubin's advice is premature and ill-advised.

The Rest of the Story
But that's not what this post is about.

This post is about the failure of the author to disclose a significant conflict of interest with Big Alcohol.

According to a 2011 report, Dr. Rubin was at one time a member of the Medical Advisory Council of the Alcoholic Beverage Medical Research Foundation (ABMRF), which is heavily funded by the alcohol industry. Dr. Rubin is also listed as having been a recipient of grant funding from ABMRF (from 1987-1991 and in 1993). Dr. Rubin also served as an expert witness for Philip Morris on several occasions during the period 1991-2000. During this time, the Miller Brewing Company was owned by Philip Morris.

Moreover, it appears that the conflict of interest with Big Alcohol is indeed current, as Dr. Rubin himself lists
himself as being a consultant to the Medical Advisory Board of ABMRF.
He lists the relationship as "Current Consultantships - Medical Advisory
Council, Alcoholic Beverage Medical Research Foundation 1992-present."

Clearly, Dr. Rubin has a conflict of interest by virtue of his relationship with Big Alcohol, including having been the recipient of grant funding from an alcohol industry foundation and having served on the board of that alcohol industry foundation.

However, nowhere in the article can I find any disclosure of this conflict.

I can't even find a disclosure of this conflict in a 2004 article in Atherosclerosis that reports the results of a study designed to identify potential benefits of alcohol consumption.

And in a 2013 article that reports the results of an investigation into potential benefits of alcohol consumption, the conflict of interest disclosure statements reads: "No potential conflicts of interest were disclosed."

Interestingly, Dr. Rubin testified that the research conducted by the Council for Tobacco Research (CTR) was of high scientific quality and that the scientific review adhered to widely recognized scientific standards. As the CTR was recently found by a federal court to be part of a vast conspiracy of fraud and deceit by the tobacco industry, Dr. Rubin's testimony in these tobacco cases sheds doubt on his scientific objectivity and judgment.

But the most serious issue here is not the poor medical advice. All physicians are entitled to their opinions. What they are not entitled to do, however, is to issue national recommendations on an issue as important as alcohol use if they have severe financial conflicts of interest, especially if they fail to reveal those conflicts.

The conflict of interest disclosure guidelines for the journal (Alcoholism: Clinical and Experimental Research) seem pretty clear. The guidelines require the disclosure of "any potential sources of conflict of interest," and they do not limit the disclosure to only a certain number of years. Here is the full disclosure requirement guideline:

"Conflict of Interest: This publication requires that all
authors disclose any potential sources of conflict of interest.
Any interest or relationship, financial or otherwise, that
might be perceived as influencing an author's objectivity
is considered a potential source of conflict of interest.
These must be disclosed when directly relevant or
indirectly related to the work that the authors describe in
their manuscript. Potential sources of conflict of
interest include but are not limited to patent or stock
ownership, membership of a company board of directors, membership
of an advisory board or committee for a company, and consultancy
for or receipt of speaker's fees from a company. The
existence of a conflict of interest does not preclude
publication in this journal."

"If
the authors have no conflict of interest to declare, they
must also state this at submission. It is the responsibility of the
corresponding author to review this policy with all authors and
to collectively list in the cover letter to the Editor, in
the manuscript (in the footnotes, or Conflict of Interest
or Acknowledgements section), and in the online submission
system ALL pertinent commercial and other relationships."
The rest of the story is that this commentary deceives readers by failing to disclose the fact that the author was the recipient of grant funding from an alcohol industry foundation and that he served on a board of that foundation. It also fails to disclose that the author is currently a consultant to the board. Surely, these conflicts are relevant to the ability of readers to properly evaluate the validity of the article's recommendations. I suspect that there are thousands of readers of this article who would be very surprised to find out "the rest of the story."

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 25 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.